Regulatory Affairs -Pharmaceutical Development Services

Pharmaceutical Development Services is one of Europe's leading pharma consultancies.We'll manage your drug or device development programme from research to product launch.

PDS was established in 2000 by Michael Gamlen, Managing Director and a number of senior colleagues, who are all experts in formulation development, manufacturing, quality assurance, regulatory affairs and clinical trials. In 2004 PDS bought Tudor Health Care, a long established regulatory consultancy with complementary expertise. The head office near Nottingham was retained and there is also an office in Guildford. PDS offer consultancy for UK, EU and international companies and organisations.

We have worked for small start up companies, major multinationals, US and European based biotechnology companies, generic manufacturers, US based medical device companies and multinational OTC Health Care providers.

Our trusted experts will ensure you receive the best advice and help to get your products to market

Sectors Served

Pharmaceuticals (Prescription and OTC)

API Synthesis

Biotechnology

Medical Devices

Herbal Remedies and Borderline Substances

Cosmetics

Services Include

Regulatory AffairsDevelopment of Regulatory Strategy for Clinical Trial Programmes and Marketing Authorisations in the EURegulatory Due Diligence for potential In-licensing CandidatesPreparation for Scientific Advice meetings with the EMEA and National AgenciesManagement of Centralised, Decentralised and Mutual Recognition ProceduresResponding to Regulatory QuestionsCompilation of Clinical Trial Applications, including IMPD writing, and Submission to National Agencies and Ethics CommitteesCompilation of Marketing Authorisation applications in e-CTD FormatMedical Device RegistrationAdvice on Permitted Ingredients and Claims for Cosmetics

PharmacovigilanceAdvice on establishment of a pharmacovigilanceProvision of a 24 hour Telephone Answering Service for Adverse Event MonitoringProvision of a Pharmacovigilance Qualified Person serviceReporting of Serious Adverse Drug Reactions to EU agenciesPreparation of Periodic Safety Update Reports (PSURs)

Pharmaceutical and chemical servicesProject Management of all aspects of Product DevelopmentSuccessful Outsourcing of Pharmaceutical and Chemical DevelopmentManagement of Packaging, Labelling and Manufacturing of Clinical Trials MaterialsNew product development on an out-sourced basisIdentification of low cost, high quality API and synthetic intermediate sourcesTechnical Due DiligenceSupply Chain Development and Management

Medical WritingPreparation of Clinical Study ReportsPreparation of IMPDs and Investigator BrochuresWriting Non-clinical and Clinical Overviews and Summaries in accordance with CTD Requirements

Interim Management Independent support for your team in the regulatory and QC areasLaboratory Management

TrainingIn-house and public courses covering all aspects of product development and supply change management including GMP, Six Sigma, Lean Manufacturing, Pharmacokinetics, Auditing, Stability Testing, Tablet Development and Regulatory Affairs